Data on MYRBETRIQ® (mirabegron) as Treatment for Overactive Bladder Presented at AUA 2013

Data on MYRBETRIQ® (mirabegron) as Treatment for Overactive Bladder Presented
                                 at AUA 2013

PR Newswire

SAN DIEGO, May 7, 2013

SAN DIEGO, May 7, 2013 /PRNewswire/ --Astellas Pharma US, Inc. ("Astellas"),
a U.S. subsidiary of Tokyo-based Astellas Pharma Inc. (Tokyo: 4503), announced
today that results of three studies of MYRBETRIQ^® (mirabegron) as a treatment
for overactive bladder (OAB) with symptoms of urge urinary incontinence,
urgency and urinary frequency were presented in poster sessions at the
American Urological Association Annual (AUA) Meeting in San Diego.

The first two studies demonstrated the efficacy and tolerability of MYRBETRIQ
via separate prospective pooled analyses of three randomized Phase 3 trials.
The third study, the 12-week Phase 2 Symphony trial, assessed combination
therapy of MYRBETRIQ and VESIcare^® (solifenacin succinate) versus VESIcare
alone.

"The pooled analyses represent an important body of evidence supporting
MYRBETRIQ as a potential treatment option for OAB symptoms of urge urinary
incontinence, urgency and urinary frequency," said Shontelle Dodson, PharmD,
Senior Director, Astellas Scientific and Medical Affairs.

About MYRBETRIQ

MYRBETRIQ was approved by the U.S. Food and Drug Administration (FDA) on June
28, 2012, and is indicated for the treatment of OAB with symptoms of urge
urinary incontinence, urgency and urinary frequency. Mirabegron is also
approved for use in Japan, the European Union and Canada.

Indications and Usage for MYRBETRIQ

MYRBETRIQ (mirabegron) is a beta-3 adrenergic agonist indicated for the
treatment of overactive bladder (OAB) with symptoms of urge urinary
incontinence, urgency and urinary frequency.

IMPORTANT SAFETY INFORMATION for MYRBETRIQ

  oMyrbetriq can increase blood pressure. Periodic blood pressure
    determinations are recommended, especially in hypertensive patients.
    Myrbetriq is not recommended for use in severe uncontrolled hypertensive
    patients (defined as systolic blood pressuregreater than or equal to
    180mm Hg and/or diastolic blood pressuregreater than or equal to110 mm
    Hg).
  oUrinary retention in patients with bladder outlet obstruction (BOO) and in
    patients taking antimuscarinic medications for the treatment of OAB has
    been reported in postmarketing experience in patients taking mirabegron. A
    controlled clinical safety study in patients with BOO did not demonstrate
    increased urinary retention in Myrbetriq patients; however, Myrbetriq
    should be administered with caution to patients with clinically
    significant BOO. Myrbetriq should also be administered with caution to
    patients taking antimuscarinic medications for the treatment of OAB.
  oSince Myrbetriq is a moderate CYP2D6 inhibitor, the systemic exposure to
    CYP2D6 substrates such as metoprolol and desipramine is increased when
    co-administered with Myrbetriq. Therefore, appropriate monitoring and dose
    adjustment may be necessary, especially with narrow therapeutic index
    drugs metabolized by CYP2D6, such as thioridazine, flecainide, and
    propafenone.
  oMost commonly reported adverse reactions (>2% and >placebo) for Myrbetriq
    25 mg and 50 mg vs placebo, respectively, were hypertension (11.3%, 7.5%
    vs 7.6%), nasopharyngitis (3.5%, 3.9% vs 2.5%), urinary tract infection
    (4.2%, 2.9% vs 1.8%), and headache (2.1%, 3.2% vs 3.0%).

For full Prescribing Information for Myrbetriq, please visit
www.Myrbetriq.com.

Indications and Usage for VESIcare^®

VESIcare is a muscarinic antagonist indicated for the treatment of overactive
bladder with symptoms of urge urinary incontinence, urgency and urinary
frequency.

IMPORTANT SAFETY INFORMATION for VESIcare^®

  oVESIcare is contraindicated in patients with urinary retention, gastric
    retention, uncontrolled narrow-angle glaucoma, and in patients with
    hypersensitivity to the product.
  oAngioedema of the face, lips, tongue and/or larynx have been reported with
    VESIcare. Cases of angioedema have been reported to occur hours after the
    first dose or after multiple doses. Angioedema associated with upper
    airway swelling may be life threatening. If involvement of the tongue,
    hypopharynx, or larynx occurs, VESIcare should be promptly discontinued
    and appropriate therapy and/or measures necessary to ensure a patent
    airway should be promptly provided. Anaphylactic reactions have been
    reported rarely in patients treated with VESIcare. VESIcare should not be
    used in patients with a known or suspected hypersensitivity to solifenacin
    succinate. In patients who develop anaphylactic reactions, VESIcare should
    be discontinued and appropriate therapy and/or measures should be taken.
  oVESIcare should be administered with caution to patients with bladder
    outflow obstruction, decreased gastrointestinal motility, controlled
    narrow-angle glaucoma, or reduced renal or hepatic function. Doses of
    VESIcare higher than 5 mg are not recommended in patients with severe
    renal impairment, moderate hepatic impairment, or when administered with
    ketoconazole or other potent CYP3A4 inhibitors. Use of VESIcare in
    patients with severe hepatic impairment is not recommended.
  oAnticholinergic central nervous system (CNS) effects have been reported
    with VESIcare use, including headache, confusion, hallucinations and
    somnolence. Patients should be monitored for signs of anticholinergic CNS
    effects, particularly after beginning treatment or increasing dose, and be
    advised not to drive or operate heavy machinery until they know how
    VESIcare affects them. If a patient experiences these effects, dose
    reduction or drug discontinuation should be considered.
  oIn placebo-controlled studies, for the 10-mg dose, three intestinal
    serious adverse events were reported (one fecal impaction, one colonic
    obstruction, and one intestinal obstruction). For the 5-mg dose, one
    serious adverse event (angioneurotic edema) was reported.
  oIn placebo-controlled studies, the most common adverse events reported by
    patients were dry mouth (10.9%, 27.6%, 4.2%), constipation (5.4%, 13.4%,
    2.9%), blurred vision (3.8%, 4.8%, 1.8%), and urinary tract infection
    (2.8%, 4.8%, 2.8%) with VESIcare 5 mg, 10 mg, and placebo, respectively.

For complete prescribing information for VESIcare, go to www.vesicare.com.

About Overactive Bladder

According to the National Association for Continence, one in five adults has
overactive bladder. However, recent studies have found that many more people
may be affected, and have not talked to their physicians out of embarrassment
or belief that OAB cannot be treated. For people with OAB, inappropriate
signals are sent to the muscles in the bladder causing them to contract before
the bladder is full. These bladder contractions may cause strong, sudden
urges, and a frequent need to go to the bathroom, sometimes without any
advance warning. Many patients manage their symptoms by restricting fluids,
carrying extra clothing and "mapping" bathroom locations wherever they go.

About Astellas

Astellas Pharma US, Inc., located in Northbrook, Illinois, is a U.S. affiliate
of Tokyo-based Astellas Pharma Inc. Astellas is a pharmaceutical company
dedicated to improving the health of people around the world through the
provision of innovative and reliable pharmaceutical products. The organization
is committed to becoming a global category leader in focused areas by
combining outstanding R&D and marketing capabilities. For more information
about Astellas Pharma US, Inc., please visit our website at www.astellas.us.

Abstract 1372: May 6, 2012 at 3:30 p.m. PT

Abstract 1957: May 7, 2013 at 3:30 p.m. PT

Abstract 1958: May 7, 2013 at 3:30 p.m. PT

SOURCE Astellas Pharma US, Inc.

Website: http://www.astellas.us
Contact: MEDIA, Jenny M. Kite, Astellas, (224) 205-5405,
Jenny.Kite@Astellas.com, or Joni Ramirez, Edelman, (323) 532-0746,
Joni.Ramirez@Edelman.com
 
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